Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Guidance for Industry; Availability
fda-food · Food and Drug Administration · Rule · Published 2016-04-15 · 81 FR 22174
Document
Document number
2016-08684
Federal Register citation
81 FR 22174
CFR reference
21 CFR 106
Type
Rule
Action
Notification of availability.
Category
fda-food
Sub-agency
Food and Drug Administration
Publication date
2016-04-15
HHS docket
Docket No. FDA-2014-D-0044
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.'' The guidance describes our current thinking on the manufacturing of exempt infant formula in relation to the requirements for CGMPs, quality control procedures, conduct of audits, and records and reports that apply to non-exempt infant formulas.